A Phase 1 interventional study of Fadanafil and Placebo in Healthy Subject, sponsored by Sihuan Pharmaceutical Holdings Group Ltd.. Completed at 1 site in China. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-18.
Sponsored by Sihuan Pharmaceutical Holdings Group Ltd. · Phase 1, Interventional, and Treatment
The purpose of this study is to evaluate the safety , tolerability, and pharmacokinetics of ascending single dose Fadanafil (XZP-5849)in Chinese healthy adult male subjects. This is the first XZP-5849 clinical study
XZP-5849 is a selective phosphodiesterase (PDE5) inhibitor. The proposed randomized Phase 1 trial is a double-blind, placebo-controlled, single ascending dose study in approximately 66 Chinese healthy adult male subjects. The study consists of 8 cohorts (1 cohort per dose level). Each subject will participate in only one cohort.
Sihuan Pharmaceutical Holdings Group Ltd. is the lead sponsor of 23 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
8 group: 12.5mg one dose; 25mg one dose; 50mg one dose; 100mg one dose; 200mg one dose; 300mg one dose; 400mg one dose; 500mg one dose
Drug: Fadanafil
8 group: 12.5mg one dose; 25mg one dose; 50mg one dose; 100mg one dose; 200mg one dose; 300mg one dose; 400mg one dose; 500mg one dose
Drug: Placebo
Dose escalation for 8 groups: 12.5mg one dose, 25mg one dose, 50mg one dose, 100mg one dose, 200mg one dose, 300mg one dose, 400mg one dose, 500mg one dose
Also known as: 5849
Dose escalation for 8 groups: 12.5mg one dose, 25mg one dose, 50mg one dose, 100mg one dose, 200mg one dose, 300mg one dose, 400mg one dose, 500mg one dose
Electrocardiogram (ECG)
To evaluate subject ECG Changing information
Time frame: Change from Baseline to 1, 2,4,6,8,12,24,36,46 hours after dosing.
Pharmacokinetic Parameter AUC(0-24)
AUC(0-24) of Fadanafile is area under the curve
Time frame: Pre dose and 0.25,0.5,0.75,1,1.5, 2, 2.5, 4, 6,8,12, 24,36 hours after Dosing
Blood Pressure and Heart Rate
To evaluate subject Blood Pressure and Heart Rate Changing information
Time frame: Change from Baseline to 1, 2,4,6,8,12,24,36,46 hours after dosing
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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Sihuan Pharmaceutical Holdings Group Ltd.